Oliver Brüstle is the patent holder for isolated and
purified neural precursor cells produced from human embryonic stem cells
(hESCs) used to treat neurological diseases.

The Federal Patent Court ruled that Brüstle's patent was
invalid, as it covers processes for obtaining precursor cells from hESCs. On
appeal, the CJEU was asked to interpret the concept of "human embryo," which is
not defined in Directive 98/44/EC on the legal protection of biotechnological
inventions.

The purpose of Directive 98/44 is to establish a framework
for the legal protection of biotechnological inventions. Article 6.1 provides
that inventions must be considered unpatentable where their commercial
exploitation would be contrary to public order or morality.

The court was asked, "What is meant by the term 'human
embryos" in Article 6(2)(c) of Directive 98/44 ?" Article 6.2.c. cites the use
of human embryos for industrial or commercial purposes as an example of
inventions that are considered unpatentable.

The question is whether the exclusion from patentability of
the human embryo covers all stages of life from fertilization of the ovum, or
whether other conditions must be met—for example, that a certain stage of
development be reached.

The case raised very interesting legal and ethical issues,
in particular how the right to human dignity related to the dispute. Although a
fundamental right under German constitutional law and jurisprudence, the right
to human dignity has been recognized as an unwritten principle of EU law, and
undoubtedly played a significant part in the outcome of this case.

The development from conception begins with a few totipotent
cells. Each cell has the capacity to develop into a complete human being. The
court viewed totipotent cells as representing the first stage of the human
body, and ruled they must therefore be legally categorized as embryos.

The court emphasized that whether this categorization must
be recognized from before or only after implantation is irrelevant. This means
that every totipotent cell, whatever the means by which it has been obtained,
is an embryo, and that any patentability must be excluded. This definition
covers unfertilized ova into which a cell nucleus from a mature cell has been
transplanted.

The court ruled that characterizing a totipotent cell as an
embryo does not resolve the issue, as an embryo quickly develops into a
blastocyst made up of pluripotent cells that can develop into all kinds of
cells to form all the organs of the human body. These cells cannot develop
separately into a complete human being. While the court found that blastocysts
as a whole must be categorized as an embryo, it said individual pluripotent
cells in isolation are not.

Most of the EU member states take the view that pluripotent
stem cells are not human embryos given that hESCs, taken in isolation, are no
longer capable of developing into a complete individual. However, the court
said it is not possible to ignore the origin of this pluripotent cell. The
court interpreted Article 6.2.c. of Directive 98/44/EC on the legal protection
of biotechnological inventions as an invention that must be excluded from
patentability where the application of the technical process for which the
patent is filed necessitates the prior destruction of human embryos or their
use as base material, even if the description of that process does not contain
any reference to the use of human embryos.

The exception to the non-patentability of uses of human
embryos for industrial or commercial purposes concerns only inventions for
therapeutic or diagnostic purposes that are applied to the human embryo and are
useful to it. If you read the ruling as saying that any invention based on
hESCs is unethical and therefore cannot be patented, then the ruling will have
major implications for the commercialization of stem cell-based technologies in
the EU, especially if it fosters the idea that stem cell research is inherently
immoral.

It will take several years for the European Patent Office,
national patent offices and various courts to take up the issue and interpret
the decision. In one view, companies may end up relying on keeping
manufacturing processes a trade secret instead of relying on patents since the
European Medicines Agency keeps data submitted for regulatory approval private
for eight years and blocks others from using this information for two
additional years.

While the decision could spur development of
therapies—because it could free up hESC research from patent infringement—it
could still prove to be harmful, as the far-reaching decision bans patents on
any downstream products using cell lines that required the destruction of human
embryos for violating respect for human dignity.